Diabetes drug's effect like 'kryptonite'

Timothy Jernigan stopped taking his diabetes medicine about a week ago, afraid the pills were hurting more than helping.

A diabetes patient for about 10 years, Jernigan in January had switched to Avandaryl, a diabetes treatment made by GlaxoSmithKline. Then the 46-year-old gained 10 pounds in three months. His blood pressure and cholesterol levels went out of control. Where he once rose at 5 a.m. for his job in Holly Springs, fatigue made it hard to get out of bed.

"Most times I feel like Superman, but it was like somebody had put some kryptonite in my pockets," he said.

When Jernigan read that Avandia, another GSK diabetes drug, had been linked to an increased risk of heart attack, he checked his own medicine.

He saw that Avandaryl contains rosiglitazone, (pronounced "row-zee-glit-a-zone") the same active ingredient as in Avandia. He stopped taking Avandaryl and called his doctor. Now he wants answers.

So does Congress.

In a hearing today before the House oversight committee, a GSK executive, medical experts and a drug-safety regulator will testify about how much was known about rosiglitazone before the New England Journal of Medicine published data May 21 linking the drug to a 43 percent increased heart-attack risk.

Lawmakers are worried that the Food and Drug Administration and the British drug maker did not adequately warn patients and their doctors about the possible health risks of Avandia, Avandaryl and Avandamet, the three GSK diabetes drugs containing rosiglitazone.

Congress has been calling for stronger drug safety measures and controls, and the hearing could provide the ammunition to force changes at the FDA.

Clues that rosiglitazone might adversely affect the heart emerged less than a year after the FDA approved Avandia in 1999.

In a letter dated March 15, 2000, Dr. John Buse, director of the University of North Carolina's Diabetes Care Center in Chapel Hill, alerted the FDA about his concerns about Avandia's safety. Buse is one of the medical experts scheduled to testify today.

Public outcry begins

Last year, GSK submitted data to the FDA indicating hat rosiglitazone increases heart risks 30 percent to 40 percent. But public awareness wasn't awakened until the New England Journal published data compiled by Dr. Steven Nissen, a leading cardiologist at the Cleveland Clinic in Ohio, that suggested an even higher risk.

The GSK data and the data published in the New England Journal weren't conclusive, because they were based on statistical analysis fraught with scientific limitations.

GSK, which has operations in Research Triangle Park, strongly disagreed with Nissen's findings, and the head of the FDA said regulators have done everything right.

Patients such as Jernigan have seized on the study results as an explanation for puzzling changes that they noticed in their health while they were on rosiglitazone.

When Jernigan saw his doctor this week, an electrocardiogram --a recording of his heartbeat -- showed that his heart rhythm was out of whack. His doctor referred him to a heart specialist, Jernigan said, and changed his Avandaryl prescription, but only because Jernigan insisted.

"I basically told her I wouldn't take this stuff," Jernigan said.

Hit by heart attack

Gary Register, 46, of Apex, thinks that he should never have taken rosiglitazone. Disabled since a 1990 car accident left him with chronic pain, numbness in his left arm and hand and memory problems, the former insurance agent had a heart attack Oct. 22, 2000, about nine months after he switched to Avandia.